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510(k) Data Aggregation
(220 days)
The CardioGard Emboli Protection Cannula combines the function of a standard arterial cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The CardioGard Emboli Protection Cannula is intended for perfusion of the ascending aorta during short term (≤ 6 hours) cardiopulmonary bypass (CPB) procedures. The CardioGard suction lumen is intended for the removal of particulate emboli during surgical procedures that require CPB.
The CardioGard Emboli Protection Cannula, shown below, is a disposable 24 French double lumen arterial cannula. The cannula functions to deliver oxygenated blood to the heart during procedures requiring cardiopulmonary bypass (CPB), while at the same time suctioning blood and embolic matter away from the surgical field. The arterial cannula is inserted centrally in the ascending aorta. The CardioGard Emboli Protection Cannula features a tip configuration which diffuses oxygenated blood from the heart-lung machine to the ascending aorta through the Cannula Outlet, while also aspirating blood and embolic matter through the Suction Lumen Inlet. The flow rates through the two cannula lumens are carefully controlled so that emboli are suctioned back to the CPB machine for filtration while still enabling sufficient blood flow into the aorta.
Based on the provided text, the device being discussed is the CardioGard Emboli Protection Cannula. It's important to note that this document is a 510(k) summary for a medical device and not a submission for an AI/ML-based device. Therefore, the questions about "AI vs without AI assistance," "standalone algorithm performance," and "ground truth establishment for training set" are not directly applicable in the context of this device's approval process as described.
However, I can extract information related to the device's acceptance criteria and the study that proves it meets them, adapting the requested structure to fit the available details.
The core of the "acceptance criteria" here is "substantial equivalence" to a predicate device, demonstrated through various non-clinical and clinical tests.
Acceptance Criteria and Device Performance for CardioGard Emboli Protection Cannula
The acceptance criteria for the CardioGard Emboli Protection Cannula are primarily demonstrated through its substantial equivalence (safety and effectiveness) to predicate devices, namely the Embol-X Access Device/Aortic Cannula and the Embol-X Intra-Aortic Filter. This equivalence is shown through comparative testing against specific performance attributes.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document describes "acceptance criteria" primarily through comparative performance to a predicate device and meeting pre-defined thresholds in various non-clinical tests. "Reported device performance" here refers to the outcomes of these tests. As this is not an AI/ML context, metrics like sensitivity/specificity are not applicable.
| Acceptance Criteria (Demonstrated Substantial Equivalence / Performance Threshold) | Reported Device Performance (CardioGard Emboli Protection Cannula) |
|---|---|
| Intended Use Equivalence: Combines arterial perfusion and embolic particle capture during CPB. | Functionally equivalent to the combined Embol-X Aortic Cannula and Intra-Aortic Filter. Intended for perfusion of ascending aorta during short term (≤ 6 hours) CPB procedures, with the suction lumen intended for removal of particulate emboli. |
| Use Duration Equivalence: Capable of use for the entire duration of CPB surgery (≤ 6 hours). | Can be used for the entire duration of CPB surgery (≤ 6 hours), similar to the Embol-X Cannula. (This is a differentiating factor from the Embol-X filter, which has a 60-minute limit). |
| Design Similarity & Functionality: Curved tip with two ports (perfusion + embolic particle removal). | Two lumen, curved tip with two ports: one for aortic perfusion, one for suction of embolic particles. Main difference is the method of embolic particle removal (suction vs. filter). In vitro side-by-side comparison testing demonstrated substantial equivalence of these two methods. |
| Dimensions Equivalence: Similar tip size, length, and tube diameters. | Tip Size: 24Fr, Length: 30cm, Main tube diameter: 3/8", Suction tube diameter: 1/4". These are similar to the predicate Embol-X Access Device/Aortic Cannula (Tip Size: 24Fr; 20 Fr effective flow, Length: 28 cm, Main tube diameter: 3/8"). |
| Pressure Drop Performance: Acceptable pressure drop for arterial perfusion. | Demonstrated smaller (better) pressure drop compared to the predicate Embol-X Cannula at all measured flow rates (3, 4, 5, and 6 l/min) in in vitro side-by-side comparison testing. |
| Back Pressure Equivalence: Acceptable back pressure performance. | Demonstrated substantially equivalent back pressure compared to the predicate Embol-X Cannula in side-by-side comparison testing. |
| Hemolysis Potential Equivalence: Acceptable levels of blood damage. | Demonstrated substantially equivalent hemolysis potential compared to the Embol-X Cannula and Filter under worst-case conditions (highest flow rates, simulating 6-hour CPB). |
| Embolic Particle Capture Efficacy: Effective removal of embolic particles. | Demonstrated substantially higher embolic particle capture compared to the Embol-X Cannula and Filter under test conditions simulating a 6-hour CPB procedure. Additionally, an animal study showed capture of a mean of 77% of injected osseous embolic particles. |
| Biocompatibility: Materials are safe for contact with blood. | Materials (PVC, Nirosta, ABS) are commonly used in medical devices and confirmed biocompatible according to ISO 10993-1:2009 for externally communicating devices in contact with circulating blood for limited (<24 hours) duration. All tests (cytotoxicity, irritation, sensitization, acute systemic toxicity, mutagenicity/genotoxicity, hemocompatibility) passed. |
| Sterilization: Device is sterile, non-pyrogenic, and single-use. | EtO sterilized to an SAL of 10⁻⁶ (overkill method, half-cycle technique in accordance with EN ISO 11135-1:2008). LAL test verified pyrogen-free. Single-use, disposable. |
| Shelf Life: Maintain functionality and package integrity for specified duration. | Accelerated aging equivalent to 2 years passed functionality (Visual Inspection, Dimensional Verification, Back Pressure, Pressure Drop, Air Leakage, Liquid Leakage, Force at Break) and package (Peel Strength, Burst Test, Dye Penetration Test) testing, supporting a 2-year labeled shelf life. |
| Clinical Safety & Efficacy: Comparable safety profile and effective in clinical use, demonstrating benefit in reducing brain lesions. | Safety: Similar type and incidence rates of adverse events and serious adverse events compared to control group. Most were isolated and not unexpected for cardiac surgery. Efficacy: CardoGard device effectively removed measurable quantities of embolic particles. Fewer CardioGard subjects exhibited new brain lesions post-surgery (42.8% vs. 66.7% for control), with statistically significant difference (p<0.05). Average and total volume of new brain lesions significantly smaller for CardioGard subjects (p<0.05). |
2. Sample Sizes Used for the Test Set and Data Provenance
- Non-Clinical In Vitro Testing: Not explicitly stated for each test (e.g., number of devices tested for pressure drop, hemolysis, embolic capture).
- Animal Testing: 10 pigs (7 using CardioGard, 3 controls using commercially available aortic perfusion cannula).
- Clinical Testing: A prospective, randomized, multi-center, double-blind clinical study. The exact number of subjects is not explicitly stated in the provided abstract, but comparison percentages (42.8% vs 66.7%) imply a sufficient sample size to achieve statistical significance (p<0.05).
- Data Provenance: The manufacturer is CardioGard Medical Ltd. in Israel. The clinical study is described as "multi-center," which typically implies data from various institutions, potentially in different geographical locations, but the specific countries are not mentioned. It was a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For Clinical Study: "Core-lab evaluators" are mentioned for the diffusion weighted magnetic resonance imaging (DW-MRI) evaluation of new brain lesions. The number and qualifications of these evaluators are not specified in the provided text.
4. Adjudication Method for the Test Set
- The clinical study was "double-blind (subject and core-lab evaluators)," suggesting independent evaluation. However, the specific adjudication method (e.g., 2+1, 3+1 consensus) for discrepancies among evaluators is not described. For non-clinical tests, "acceptance criteria" imply objective measurements rather than expert consensus adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This is not an AI/ML-based device where human reader improvement with AI assistance would be relevant. The clinical study compares device effectiveness in patients (CardioGard vs. control cannulas), not human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is a physical medical device (cannula), not an algorithm or software. Its "standalone" performance is assessed through its physical properties and function in in-vitro, animal, and clinical settings.
7. The Type of Ground Truth Used
- Non-Clinical/Bench Testing: The "ground truth" is based on objective physical measurements and validated testing protocols (e.g., standardized methods for pressure drop, flow rates, hemolysis levels, particle capture rates).
- Animal Study: The "ground truth" for embolic particle capture was the direct measurement of injected osseous embolic particles captured.
- Clinical Study: The "ground truth" for efficacy was based on quantitative and qualitative assessment of diffusion weighted magnetic resonance imaging (DW-MRI) for new brain lesions, and adverse event reporting for safety. This is a form of outcomes data (imaging markers and clinical events).
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI/ML model that requires a training set. The "development" and "validation" involve engineering design, material science, and testing, not model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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